EndoBarrier Versus Intragastric Balloon in Obese Diabetic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Sponsor:
Information provided by (Responsible Party):
Anna Casu, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier:
NCT01848795
First received: May 3, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

Obese patients with Type 2 diabetes (T2D) have a 80-98% chance of having their disease cured or improved following bariatric surgery. This could be explained by weight loss or by changes of nutrient absorption or gut hormone secretion. The comparison of glucose metabolism in patients undergoing malabsorptive or mechanical procedures will clarify this matter. EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical procedures while the endoscopically placed intragastric balloon induces weight loss with a mechanical action.

The present study hypothesis is that the bypass of the first portion of the intestine obtained with the EndoBarrier will be more effective in improving glucose metabolism than the reduction of food intake obtained with the intragastric balloon. Since similar weight loss is expected in the two groups, the study will aid in understanding the mechanisms behind the metabolic improvement seeing after intestine bypass.


Condition Intervention Phase
Type 2 Diabetes
Obesity
Device: EndoBarrier Gastrointestinal Liner
Device: BioEnterics Intragastric Balloon System
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Metabolic Effects of EndoBarrier Versus Intragastric Balloon in Obese Patients With Type 2 Diabetes.

Resource links provided by NLM:


Further study details as provided by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies:

Primary Outcome Measures:
  • Glycated hemoglobin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    measurement of diabetes metabolic control


Estimated Enrollment: 90
Study Start Date: May 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EndoBarrier Gastrointestinal Liner
The treatment in this arm is the endoscopic positioning of the EndoBarrier Gastrointestinal Liner and follow up.
Device: EndoBarrier Gastrointestinal Liner
Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
Other Name: produced by GI Dynamics
Active Comparator: Intragastric Balloon
The treatment in this arm is the endoscopic positioning of the Intragastric Balloon System as a comparator and follow up.
Device: BioEnterics Intragastric Balloon System
Endoscopy placement of EndoBarrier, and clinical and biochemical follow up

Detailed Description:

Bariatric surgery is an effective therapy for obesity. Malabsorption-based surgical techniques (excluding the first part of the gastrointestinal tract from the alimentary circuit) are also effective in correcting T2D, even before any significant weight loss has occurred. Proposed mechanisms to explain this beneficial effect include caloric restriction, altered secretion of gut hormones due to duodenal exclusion or due to contact of undigested food with the jejunal mucosa, pancreatic islet hyperfunction, changes of intestinal flora, mucosal inflammation, and/or changes in the biliary acid re-circulation.

EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical procedures while the endoscopically placed intragastric balloon induces weight loss with a mechanical action.

The present study is a prospective, randomized clinical trial. It will compare the metabolic compensation between patient treated with EndoBarrier and patient treated with Intragastric Balloon.

The aims will be: comparison of glycemic control as measured by hemoglobin A1c (HbA1c), change in oral hypoglycemic drug consumption and body loss from baseline and during follow up in the two groups; evaluation of mechanisms implicated in glycemic control by measuring basal and stimulated insular hormones, glucose levels and gastrointestinal hormones; creation of a bio-bank and dedicated database to collect biological samples for further future studies.

Obese adult T2D patients (BMI ≥ 30) with diabetes duration <10 years will be randomized to receive either EndoBarrier (n=45) or Intragastric Balloon (n=45). The devices will be implanted and kept in place for the first 12 months of study and then removed. Clinical and biochemical data will be collected every 3 months during the 12 months of implant and for the subsequent 12 months after removal.

Statistics describing variables at baseline, at subsequent visits and at the end of the study will be produced for both groups of patients. The Student's t-test will be used for a cross-sectional analysis while the mixed model system will be used for longitudinal observations. Multivariate analysis will also be applied to better characterize differences that may be seen between the two groups.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (18-60 year old)
  • Type 2 Diabetes diagnosed less than 10 years ago
  • Obesity (BMI > 30)

Exclusion Criteria:

  • pregnancy
  • inflammatory bowel disease
  • peptic ulcer
  • gastrointestinal disease preventing device positioning
  • pancreatitis,
  • coronary artery disease
  • symptomatic pulmonary disease
  • infection at the time of device placement,
  • high risk of gastrointestinal bleeding (coagulopathy, bleeding diathesis, anti-coagulant therapy, Non-Steroid Anti-Inflammatory Drugs)
  • altered GI anatomy that could affect device placement
  • contraindication of positioning of the devices as per technical description of the producer
  • C-peptide negative diabetes
  • failure to understand the study protocol or not willing to undergo planned follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848795

Contacts
Contact: Anna Casu, MD +390912192111 acasu@ismett.edu
Contact: Mario Traina, MD +390912192111 mtraina@ismett.edu

Locations
Italy
ISMETT Recruiting
Palermo, Italy, 90127
Contact: Anna Casu, MD    +390912192111    acasu@ismett.edu   
Contact: Mario Traina, MD    +390912192111    mtraina@ismett.edu   
Principal Investigator: Anna Casu, MD         
Sub-Investigator: Mario Traina, MD         
Sponsors and Collaborators
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Investigators
Principal Investigator: Anna Casu, MD The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
  More Information

No publications provided

Responsible Party: Anna Casu, Diabetology Attending, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
ClinicalTrials.gov Identifier: NCT01848795     History of Changes
Other Study ID Numbers: IRRB/30/10
Study First Received: May 3, 2013
Last Updated: May 3, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies:
Type 2 Diabetes
Obesity
gastrointestinal hormones
intestinal bypass
endoscopy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014